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Stabilized and preserved ketoifen ophthalmic compositions

a technology of ophthalmic compositions and stabilized ketoifen, which is applied in the field of ophthalmic compositions, can solve the problems of chemical or drug substances that are not compatible with hydrogen peroxide and susceptible to chemical oxidation

Inactive Publication Date: 2008-08-28
TSAO FU PAO +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many chemical or drug substances are not compatible with hydrogen peroxide, i.e., are susceptible to chemical oxidation by hydrogen peroxide.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0032]

TABLE 1Ketotifen-Perborate FormulationNaKetotifenPerborate•BoricNaFumarateNaCl4 H2ODequestAcidBorateFormulation(mg / mL)pH(mg / mL)(mg / mL)(mg / mL)(mg / mL)(mg / mL)10.3456.36.650.270.065.00.05206.36.650.270.065.00.05305.36.650.270.065.00.0540.3455.36.650.20.065.00.05

[0033]The stability of the formulations shown in Table 1 are evaluated by filling the formulations in bottles and storing the formulations at 55° C. for various times. The results are summarized in Table 2 below.

TABLE 2Ketotifen Fumarate Concentrations (mg / mL) of Samples Filledin Polypropylene Bottles and Stored at 55° C.1 Week2 Weeks4 WeeksFormulationInitialat 55° C.at 55° C.at 55° C.10.3400.3190.3230.29620.000.000.000.0030.000.000.000.0040.3360.3370.3420.341

[0034]The formulations listed in Table 2 met USP preservative effectiveness test criteria as required by FDA for the preservation of ophthalmic solutions.

[0035]The results as shown in Table 2 indicate that ketotifen is stable under evaluated conditions, especially form...

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Abstract

Ophthalmic compositions comprising ketotifen and a source of hydrogen peroxide providing an amount of hydrogen peroxide of from about 0.001 to about 0.1% (w / v) of hydrogen peroxide, and methods for the treatment and prevention of allergic conjunctivitis using these compositions are provided herein.

Description

BACKGROUND OF THE INVENTION[0001]The present invention relates to ophthalmic compositions comprising ketotifen as a pharmaceutically active agent and a source of hydrogen peroxide as a preservative for use in treating allergic conjunctivitis. U.S. Pat. Nos. 5,725,887 (the '887 patent) and 5,607,698, and application Ser. No. 11 / 078,209, all of which are expressly incorporated by reference herein in their entirety, disclose and claim methods for the preservation of ophthalmic solutions using stabilized hydrogen peroxide and compositions so preserved. However, hydrogen peroxide is a strong oxidation agent. Many chemical or drug substances are not compatible with hydrogen peroxide, i.e., are susceptible to chemical oxidation by hydrogen peroxide. Ketotifen is a pharmaceutically active agent susceptible to chemical oxidation by hydrogen peroxide. While ketotifen is not compatible with low concentrations of hydrogen peroxide when formulated at neutral pH, i.e., a pH of about 7, it has now...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/44A61P27/14
CPCA61K31/4535A61K9/0048A61P27/02A61P27/14A61K9/08A61K47/02
Inventor TSAO, FU-PAOWONG, MICHELLEYEN, SHAU-FONG
Owner TSAO FU PAO
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